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Insights+: The US FDA New Drug Approvals in June 2022

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Insights+: The US FDA New Drug Approvals in June 2022

Insights+: The US FDA New Drug Approvals in June 2022

  • The US FDA approved 2 NDAs and 2 BLA in June 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 37 novel products in 2022
  • In June 2022, the major highlights drugs were Amvuttra's approval for polyneuropathy of hereditary transthyretin-mediated amyloidosis, Skyrizi for active Crohn's disease, Olumiant for severe alopecia areata
  • PharmaShots has compiled a list of a total of 4 new drugs approved by the US FDA in June 2022

Alnylam’s Amvuttra (vutrisiran) Receives the US FDA’s Approval for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis

Amvuttra

Active ingredient: vutrisiran                                                       Approved: June 14, 2022

Company:  Alnylam Pharmaceuticals                                       Disease: Polyneuropathy of  Hereditary Transthyretin-Mediated Amyloidosis

  • The approval was based on the 9mos. results from the P-III (HELIOS-A) study evaluate Amvuttra vs patisiran in a ratio (3:1) in 164 patients with hATTR amyloidosis with polyneuropathy. The product is expected to be available in early July
  • The trial met the 1EPs & 2EPs i.e., improvement in mNIS+7 from baseline @9mos. (2.2point vs 14.8 point), 50% experienced an improvement in neuropathy impairment relative to baseline, Norfolk QoL-DN score & 10-MWT
  • Improvements in exploratory EPs, and efficacy results were consistent with 9mos. data with no drug-related discontinuations or deaths. The company provides Alnylam Assist, a patient support program that helps patients access Amvuttra, verifies insurance benefits & offers financial assistance to qualified patients

Eli Lilly and Incyte’ Olumiant (baricitinib) Receives the US FDA’s Approval as First-In-Disease Systemic Treatment for Adults with Severe Alopecia Areata

Olumiant

Active ingredient: baricitinib                                                        Approved: June 14, 2022

Company: Eli Lilly and Incyte                                                       Disease: Severe Alopecia Areata

  • The approval was based on the P-III (BRAVE-AA1 & 2) trials evaluating Olumiant (2/4mg, qd) vs PBO in 1200 adult patients with sev. AA
  • The results from both studies showed that 17-22% of patients treated with Olumiant (2mg/day) & 32-35% with 4mg/day achieved ≥80% scalp hair coverage over 3-5% in PBO @36wks.; 11-13% & 24-26% vs 1-4% achieved ≥90% or hair coverage. Under the multiplicity control plan for BRAVE-AA2, the results for Olumiant 2mg/day were not statistically significant
  • Improvements in eyebrow & eyelash coverage in patients with 4mg, qd dose @36wks., few patients discontinued treatment due to AEs. Lilly offers Olumiant Together support program to help patients access Olumiant treatment & provides a savings card for eligible commercially insured patients

AbbVie’s Skyrizi (risankizumab-rzaa) Receives the US FDA’s Approval as the First Specific Interleukin-23 to Treat Moderately to Severely Active Crohn's Disease

Skyrizi

Active ingredient: risankizumab-rzaa                                              Approved: June 20, 2022

Company: AbbVie                                                                              Disease: Active Crohn's Disease

  • The approval was based on the P-III (ADVANCE) & (MOTIVATE) as induction studies & (FORTIFY) as maintenance therapy evaluating Skyrizi vs PBO in patients with active CD
  • In the 12wk. induction studies, patients achieved endoscopic response & clinical remission while clinical response & clinical remission as early as 4wk. In the 52wk. maintenance trial, patients achieved the co-1EPs of endoscopic response & clinical remission after 1yr. while few or no symptoms were reported along with a reduction of visible signs of intestinal inflammation in both trials
  • The company offers a patient support program & co-pay card to provide patients access to Skyrizi & other therapy, and reduce out-of-pocket costs for eligible, commercially-insured patients to $5/mos.

BMS’ Breyanzi (lisocabtagene maraleucel) Receives the US FDA’s Approval for the Treatment of Large B-cell Lymphoma

Breyanzi

Active ingredient: lisocabtagene maraleucel                                      Approved: June 27, 2022

Company: BMS                                                                                      Disease: Large B-cell Lymphoma

  • The approval was based on the P-III (TRANSFORM) study evaluating Breyanzi vs standard therapy regimens in adults with LBCL that was primary refractory or relapsed within 12mos. after 1L therapy
  • The results showed improvements in EFS, CR & PFS; m-EFS (10.1mos. vs 2.3mos.); CR (66% vs 39%) with a median duration of CR (not reached); m-PFS (14.8mos. vs 5.7mos.), 97% received treatment over 47% who completed high-dose CT & autologous HSCT, well-established safety profile
  • The approval was also based on the P-II (PILOT) study which showed deep & durable responses with ORR (80%), CR rate (54%) with a median time to CR of 1mos., m-DoR (11.2mos.) while m-DoR was not reached in those patients who achieved a CR

Related Post: Insights+: The US FDA New Drug Approvals in May 2022


Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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